Z-0018-2014Class II

Getinge 46-Series Medical Washer-Disinfectors, Listing # E208196

Name: Z-0018-2014 Getinge 46-Series Medical Washer-Disinfectors, Listing # E208196
Creator: Getinge Disinfection
Published: 2013-07-30
License: https://open.fda.gov/license/

Getinge Disinfection AB / initiated 2013-07-30 / Terminated / root cause: manufacturing process

FDA source

Getinge Disinfection began a recall of Getinge 46-Series Medical Washer-Disinfectors, Listing # E208196 Product Usage: The washer disinfector is used in healthcare facilities where reusable items... on 2013-07-30. FDA classified it as Class II and gives the reason as "Getinge Disinfection AB initiated a voluntary field safety correction for the Getinge 46-Series electrically-heated Washer Disinfectors due to possible overheating". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0018-2014
Classification: Class II
Status: Terminated
Initiated: 2013-07-30
Posted: 2013-10-17
Terminated: 2015-05-11
Recalling firm: Getinge Disinfection AB
Product: Getinge 46-Series Medical Washer-Disinfectors, Listing # E208196 Product Usage: The washer disinfector is used in healthcare facilities where reusable items such as instruments, utensils, anesthesia sets, and glassware are handled for decontamination purposes.
Product code: MEC Disinfector, Medical Devices
Reason for recall: Getinge Disinfection AB initiated a voluntary field safety correction for the Getinge 46-Series electrically-heated Washer Disinfectors due to possible overheating.
Root cause tag: manufacturing process
FDA root cause: Nonconforming Material/Component
Action: Getinge USA, Inc. sent a Device Correction Notices letter dated July 26, 2013 to all affected customers via US Postal Certified Mail within the U.S. and Canada. The letter identified the affected product, problem and actions to be taken. The letter indicate that all customers will be contacted by a Getinge representative for guidance if any machine within the serial number range of affected product is within their possession. If you should have any questions or concerns regarding this field correction, please call 1-800-475-9040, press "1" and enter extension 5036.
Quantity in commerce: 143 units (142 domestically & 1 unit internationally)
Distribution: USA Nationwide in the states of AL, AR, AZ, CA, CO, FL, GA, HI, IA, ID, IL, IN, KS, LA, MA, MD, MI, MN, MO, MS, NC, NE, NH, NJ, NM, NV, NY, OH, OK, PA, PR, SC, SD, TN, TX, UT, VA, WA, WI, WV, WY and internationally in Canada.
Product codes and lots: Model # 46-4, Serial # range SEV0521184-SEV0838137

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0018-2014
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0018-2014	Class II	Terminated	Voluntary: Firm initiated	2013-10-23	2013-10-17

Product code MEC

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)